GENERAL GUIDELINES

Generally, the specimen requirements are written in a format that specifies the requested volume, storage temperature, and any special handling notes. The requested volume is an amount sufficient to allow at least two performances of the assay either singly or in duplicate. The minimum volume allows one single analysis including instrument dead volume. Storage temperature is specified as room temperature (15 - 30°C), refrigerated (2 to 10°C) or frozen (-20°C or colder). When temperature is not indicated, the sample may be stored and shipped in the most convenient manner for the client. For panels or multiple assay requests, the sample should be submitted with the physician’s priority of determination on the Test Request Form. Tests will be performed in the order of that priority. If the volume is insufficient to run all the tests requested, our Client Services department will contact the physician.

INTRODUCTION

The quality of any laboratory test result is dependent on many variables, the first of which begins with you. Your care, skill, and knowledge when preparing the patient and specimen are essential to the provision of the highest quality standards for testing and services. The patient must first be properly prepared so that the best possible specimen can be collected. Next, the actual collection of the specimen must be completed. Then, the specimen should be properly processed, packaged and transported to the laboratory in a timely manner and under environmental conditions that will not compromise the integrity of the specimen. After all of these activities take place, a quality analysis can be performed. The specimen collection and handling process can be completed by you and your staff, or by referring your patient to a Quest Diagnostics Patient Service Center. Please contact the laboratory for clarifications, if needed, prior to specimen collection.

Specific specimen requirements for each test are listed in the Test Center. Specimen requirements include information such as specimen volume, collection and transport containers as well as transport temperature. If additional information is needed for the interpretation of the test results or there are specific instructions for patient preparation, they are listed along with specimen requirements. It is critical that an adequate specimen volume is submitted for analysis. The volume requested in this directory is enough for initial analysis as well as for any confirmatory tests that must be performed. If an inadequate specimen is submitted, we may not be able to perform the initial test or required confirmatory procedures.

If repeat or confirmatory tests cannot be performed, the report will indicate that the specimen quantity submitted was “QNS” (Quantity Not Sufficient) for additional testing. When serum or plasma is to be submitted for analysis, it is good practice to collect a volume of blood that is 2 to 2.5 times the volume of serum or plasma needed for the test. As an example, if 4 mL of serum or plasma is needed for a test, collect 8 to 10 mL of blood. When an inappropriate specimen or unclear test request has been submitted, you will receive notification with instructions for resolving the problem.

HEALTH AND SAFETY PRECAUTIONS

Use universal precautions when handling specimens containing blood or other potentially infectious material. Work areas contaminated with blood or serum must be disinfected immediately with 10% bleach (hypochlorite at 0.5% final concentration) or other approved disinfectant. In the event of an exposure, administer first aid immediately, notify your manager or supervisor and seek prompt medical attention. First aid includes washing cuts and needle sticks with soap and water; flushing splashes to the nose, mouth, or skin with copious amounts of water; and irrigating eyes with clean water, saline, or sterile irrigants.

Specimens must be handled in a safe manner and according to applicable legal requirements or guidance. Information on safe specimen handling may be obtained from the U.S. Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC). In handling human specimens, the goal is to protect health care workers and ancillary staff such as transportation as well as the general public from exposures to blood and to other potentially infectious body fluids. Besides following other specimen preparation procedures included in this section, customers should, prior to sending a specimen to Quest Diagnostics, ensure that there is no leakage from or visible contamination outside the specimen container and that there are no needles or other sharps in the package that could cause injury or pathogenic exposure to anyone handling or opening the package and inner containers. Quest Diagnostics reserves the right to refuse to accept any transports that pose a safety hazard to its employees.

PATIENT PREPARATION

Many tests require that the patient be prepared in some specific way to ensure useful results. The best analytical techniques provide results that are only as meaningful as the quality of the specimen that has been submitted for analysis. Our goal is to provide you with the most useful diagnostic information possible. If you have questions about patient preparation for any test, please call Client Services for further assistance.

FASTING REQUIREMENTS

For the majority of tests performed on serum, plasma or whole blood, a fasting specimen is preferred. Non-fasting specimens often contain fat particles that can interfere with many analytical procedures. Fasting is defined as no consumption of food or beverage, other than water, for 9 to 12 hours before testing.

PATIENT AGE

It is helpful to indicate patient age and blood type so that appropriate reference ranges can be assigned for reporting purposes. On occasion, patient age will assist the technologists in choosing the appropriate initial sample dilution for the assay.

PEDIATRIC SPECIMENS

Pediatric color-coded Vacutainer® tubes are provided to facilitate special handling. Special small conical tubes with screw caps are provided to prevent evaporation of small volume samples. These tubes will hold up to 1.5 mL of specimen. Standard specimen transfer tubes should be used for larger volume samples. For urine specimens, use urine vials. Contact Client Services for information about supplies provided by Quest Diagnostics.

We generally request 1 tube per test to avoid delays in processing and to expedite turnaround time. To minimize specimen volume requirements for small children, however, only one tube is required even when multiple tests are ordered.

For pediatric specimen tubes, wrap the label around the tube just below the screw cap so the ends of the label adhere to each other and the information stipulated above can be read.

Bright orange, self-adhesive “Pediatric Sample” labels are provided. Please place one of these labels in a blank area of the Test Request Form. The Test Request Form, properly filled out and labeled, should be folded and inserted in the pediatric specimen bag.

PROVOCATION TESTSSome tests require the patient to ingest a substance. The most common are the Glucose Tolerance Tests where the patient drinks a solution containing glucose, and blood specimens are obtained before and at various times after the drink, to measure the concentration of glucose in plasma or serum. In the standard Glucose Tolerance Tests, adults ingest 75 g (10 ounces) of a glucose solution (Glucola™). Children ingest an amount of glucose proportional to their body weight (1.75 grams of glucose per kilogram of body weight, up to 75 g of glucose).

PROPER IDENTIFICATION OF SPECIMENS

Specimen LabelsAll specimens should be labeled at the time of collection with at least two patient identifiers.

The patient’s name (full last name, then full first name or initial) or a unique ID code is always required.

The second patient identifier may be one of the following:

Date of birth (month/date/year)

Other unique patient identifier that is also on the test requisition, e.g. hospital or office ID code or file number

Quest Diagnostic’s requisition number or specimen barcode label

Other barcode labels can be used if barcode matches the unique identifiers on the printed requisition (the barcode does not need to be human readable)

NOTE: Location-based identifiers are NOT acceptable, e.g. hospital room number or street address

Each specimen must have a securely affixed label with the following information:

the patient’s name written exactly as it appears on the test requisition (e.g., Doe, Jane)

a second patient identifier as noted above

your account number

date of collection

If the label is hand-written, use a ballpoint pen–do not use a felt tip pen. If glass slides are submitted, use a pencil for labeling the frosted end–two identifiers are preferred although patient’s name alone is acceptable.

When using an electronically generated Quest Diagnostics test requisition, place the label lengthwise on the tube. When submitting a specimen in a container other than the tube used to draw the sample (e.g., transfer vials), also indicate specimen type on the label (e.g., serum, plasma, urine, etc.). When submitting specimens for microbiological testing (e.g., cultures, bacterial antigen, microscopic examination), the nature and anatomic source of the sample and the specific organism(s) to be detected, if any, should be specified.

Test Requisition

Specimens must be accompanied by a paper requisition, prepared either by hand or printed from an electronic ordering system. The requisition, at a minimum should contain the following information:

Complete the “Patient Information” and “Insurance Information” sections on the requisition. Select the tests to be performed. Legibly print patient information and indicate with a check mark which party will be responsible for payment in the “Bill To” section of the requisition. Enter the ICD diagnosis code that reflects the patient’s symptoms, condition, or diagnosis and provide medical justification for the tests ordered. Complete billing information.

When ordering tests in a series (e.g., growth-hormone stimulation, glucose tolerance, etc.):

Use one test requisition.

Label each specimen with the patient’s name, date and time of collection, or site (if applicable).

Write the number of specimens on the test requisition.

Submit all specimens within a series together in one specimen bag.

Improperly labeled specimens will be rejected.

PACKAGING

The following are the minimum specimen packaging guidelines that should be followed when submitting specimens.

Ensure that all specimen container caps and lids are properly tightened to prevent leakage.

Properly complete the requisition.

Collect the specimen(s) and transfer to a proper transport container, if needed. Double check the specimen container to ensure that the device is not beyond its stated expiration date.

If using a manual test requisition, remove a -self--stick label from the bottom of the pre-printed paper test requisition and affix this label to the specimen transport container. Place on the container so that the label does not cover the handwritten patient name.

Fold the top copy (original) of the test requisition in half widthwise (top to bottom) with the patient’s name and bar code facing out. Retain the second copy for your files.

The specimen transport bag has two pouches. Place the specimen container(s) in the front pocket. Insert the requisition into the rear pocket with the bar code visible in the bottom corner of the bag.

Frozen specimens should be transported in plastic -screw--cap containers only. Frozen specimens must be placed in a separate specimen bag along with a separate test requisition. Frozen specimens cannot be split for other tests. If more than one test is ordered on a single frozen sample, we will call you to authorize which of the tests ordered you want performed before testing can proceed.

Remove the protective strip and seal the specimen bag. The protective strip must not obstruct the bar code. This will protect the test requisition from leakage and help ensure that the patient information can be entered directly into the laboratory computer by scanning of the bar code.

If the specimen has been classified as an “infectious substance,” transport in a box designed to withstand 95kPa of pressure to meet the ICAO/IATA and DOT requirements. These boxes are available from the local laboratory (See the Transporting Specimens to Quest Diagnostics section). Please inform Quest Diagnostics prior to, or at the time of our Logistics Representative -pick--up, so that proper transport arrangements can be made.

Any updates to these guidelines (or to the specimen transport supplies) will be communicated through your local Quest Diagnostics sales representative or Logistics Representative.

PROPER SPECIMEN PACKING HELPS TO EXPEDITE YOUR ORDER.

HOLDING AND SECURING SPECIMENS

While awaiting -pick--up by a Quest Diagnostics Logistics Representative, maintain specimens at room temperature or on cold packs unless otherwise noted under the “Transport Temperature” or other specimen requirement in the Test Listing.

Quest Diagnostics will provide a lock box for specimens awaiting -pick--up by a Quest Diagnostics Logistics Representative. However, customers are responsible for the security of specimens prior to -pick--up.

We recommend that the lockbox be placed in a location that is not subject or exposed to extreme temperatures

Frozen Specimens

Frozen specimens must be transported in insulated containers surrounded by an ample amount of dry ice to keep the specimen frozen until it reaches the laboratory. Thawed specimens are unsuitable for analysis. In the event a thawed specimen is received, you will be asked to resubmit an adequate specimen.

If you would like more information about sending specimens to Quest Diagnostics, please contact your Client Service Representative. Any updates to these guidelines will be communicated through the LABORATORY UPDATE and/or by your local Quest Diagnostics Sales Representative.

TRANSPORTING SPECIMENS TO QUEST DIAGNOSTICS

Needles, Sharps or Medical Waste

Do not send any needles or other sharp or breakable objects. Do not send medical waste as a diagnostic specimen since it may violate the law and create a health hazard. Properly discard used needles or other sharps prior to transport. Please note for tests requiring the submission of syringes, the needle must be removed and the syringe capped before sending to the laboratory. Ensure that there is no leakage from or visible contamination outside the specimen container.

Infectious Substances

In 2006, the U.S. Department of Transportation (DOT) changed the rules for classifying specimens for transport, consistent with the International Air Transport Association (IATA) rules that had previously been changed. Under the new rules most specimens for clinical testing may be classified as either “Exempt” specimens or “Biological Substance, Category B–UN3373” specimens, however classifying and packaging routine specimens for testing as Biological Substance, Category B ensures that appropriate packaging and precautions are taken. Only certain specimens with a higher potential to transmit severe, disabling or fatal diseases must be declared and packaged as “Infectious Substance, Category A–UN2814”. (The DOT regulations can be found at 49CFR173.134 et seq. The 2006 amendments to these regulations can be found at 71FR32258). Those needing to transport infectious substances should check with the DOT, the U.S. Centers for Disease Control (CDC) or public health authorities to determine classification of the specimen and, correspondingly, how the specimen should be packaged for transport. For example, certain cultures must be packaged as a DOT or IATA “infectious substance.” In addition, some air carriers may not consider certain specimens as suitable for air transport.

For courier transport: bacterial isolates should be submitted in a screw-cap agar slant using Trypticase soy agar with or without 5% sheep blood or Chocolate agar. Fungal specimens should be submitted in a screw-cap agar slant of Sabouraud Dextrose agar. All tubes must be appropriately labeled, tightly capped and sealed with tape or parafilm. Do not submit bacterial or fungal cultures on petri dishes. Place each isolate to be transported in a separate Tape Seal 95kPa Specimen Transport Bag with the absorbent material. It is important to use a separate bag for each isolate.

Use an “infectious substance” label, package and document according to carrier’s instructions, including any requirements for dry ice or accompanying material, e.g., alcohol.

USPS or Commercial Carrier

Commercial transport of specimens (e.g., FEDEX®, UPS™, DHL®,commercial airline or U.S. Postal Service [USPS]) is subject to various carrier requirements for documenting the contents of any package and for packaging and labeling.

Air carrier: Follow any additional packaging and documentation requirements according to carrier’s instructions and/or those issued by the IATA, including Packing Instruction.

U.S. Postal Service: Label, package and document according to U.S.Postal Service instructions (note that the U.S. Postal Service may not accept certain types of specimens).

Because different parts of the U.S. Department of Transportation (DOT) regulations apply based upon the mode of transport, check with your carrier or transportation expert about application of the DOT rules prior to submitting.

Packages originating outside of the United States must meet any applicable legal requirements of the country of origin and the U.S. Customs and/or CDC requirements for entry into the United States.

Quest Diagnostics and its affiliates will not be responsible for any liability attributable to the shipper’s improper actions or failure to comply with any applicable legal requirements. The outline of transportation requirements herein is only a summary of current law. It is provided with the understanding that you seek competent expert or legal advice about regulatory compliance, when applicable. In some cases, these requirements include employee training on these regulations. Quest Diagnostics cannot be responsible for this training. Quest Diagnostics reserves the right to refuse to accept any shipments that fail to meet legal requirements and those that pose a safety hazard to its employees.

SUPPLIES

Certain supplies necessary to draw and submit specimens for analysis by Quest Diagnostics are provided to customers as part of our testing services. Type and quantity of items must correlate to the number of specimens submitted to Quest Diagnostics for testing. Specimen collection devices supplied by Quest Diagnostics are to be used only for the collection of specimens for processing by Quest Diagnostics. Such supplies are not to be used to store or dispose of biological materials, including sharp instruments, or for any activity not connected with the collection of specimens for processing by Quest Diagnostics.